Advanced Skin Research Center

Sun City Center, United States

Advanced Skin Research Center

Sun City Center, United States

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Tan J.,INC Research | Gold L.S.,Ford Motor Company | Schlessinger J.,Advanced Skin Research Center | Brodell R.,Brodell Medical Inc. | And 4 more authors.
Journal of Drugs in Dermatology | Year: 2012

Few long-term treatment regimens for severe acne vulgaris have been investigated in clinical trials. Data were combined from two consecutive, randomized, double-blind, controlled studies to evaluate the efficacy, safety and subject satisfaction of four nine-month regimens in severe acne vulgaris treatment. Subjects were first randomized to receive doxycycline (DCN) and adapalene 0.1% - benzoyl peroxide 2.5% (A/BPO) or vehicle once daily for 12 weeks. Subjects who had at least 50% global improvement were subsequently randomized to receive A/BPO or its vehicle once daily for 24 weeks. Over nine months, there were four regimens: A/BPO and DCN followed by A/BPO, vehicle and DCN followed by A/BPO, A/BPO and DCN followed by vehicle, and vehicle and DCN followed by vehicle. Among the four regimens, A/BPO and DCN followed by A/BPO led to the highest percentage of subjects rated "clear" or "almost clear" (50.0% vs. 40.4%, 26.2% and 25.0%, respectively), biggest reduction in total lesion counts (76% vs. 70%, 51% and 47%, respectively) and greatest subject satisfaction (85.0% vs. 75.5%, 63.3% and 52.4%, respectively) at week 36. It provided a faster onset of action compared to groups started with vehicle and DCN (P<.05 at week 2). Subjects receiving A/BPO and DCN followed by vehicle experienced deterioration once the active treatment was discontinued. All regimens were safe and well-tolerated. In conclusion, efficacious initial therapy and long-term treatment are both important. An initial combination therapy with adapalene-BPO and DCN followed by longer-term adapalene-BPO treatment is an efficacious and satisfactory new regimen for severe acne subjects. Copyright © 2012 Journal of Drugs in Dermatology.


Jewell M.L.,Jewell Plastic Surgery Center | Jewell M.L.,Oregon Health And Science University | Jewell M.L.,Savin Center | Jewell M.L.,Skin and Vein Institute | And 2 more authors.
Plastic and Reconstructive Surgery | Year: 2011

Background: High-intensity focused ultrasound presents a noninvasive approach to body sculpting for nonobese patients. The purpose of this study was to evaluate the safety and effectiveness of a high-intensity focused ultrasound device for sculpting of the abdomen and flanks. Methods: Adults (aged 18 to 65 years) with subcutaneous abdominal fat greater than or equal to 2.5 cm thick who met screening criteria were randomized to receive high-intensity focused ultrasound treatment of the anterior abdomen and flanks at energy levels (a total of three passes each) of 47 J/cm (141 J/cm total), 59 J/cm (177 J/cm), or 0 J/cm (no energy applied, sham control). The primary endpoint was change from baseline waist circumference at the iliac crest level at posttreatment week 12. Subjective aesthetic assessments included the Global Aesthetic Improvement Scale and a patient satisfaction questionnaire. Safety assessments included adverse events, laboratory values, and physical examinations. Results: For the primary endpoint, in the intent-to-treat population, statistical significance versus sham was achieved for the 59-J/cm (-2.44; p = 0.01) but not the 47-J/cm treatment group (-2.06 cm; p = 0.13). In a per-protocol population, statistical significance versus sham was achieved for both the 59-J/cm (-2.52 cm; p = 0.002) and the 47-J/cm treatment groups (-2.10 cm; p = 0.04). Investigator subjective measures of global aesthetic improvement and patient satisfaction also favored each active treatment versus sham. Adverse events included mild to moderate discomfort, bruising, and edema. Laboratory values and physical examinations were unremarkable. Conclusions: Treatment with this high-intensity focused ultrasound device reduced waist circumference and was generally well tolerated for noninvasive body sculpting. Reduction in waist circumference was statistically significant with both active treatments (per protocol). © 2011 by the American Society of Plastic Surgeons.


Schlessinger J.,Advanced Skin Research Center | Dover J.S.,Skin Care Physicians | Monheit G.,Total Skin and Beauty Dermatology | Nelson D.B.,Medicis | And 3 more authors.
Dermatologic Surgery | Year: 2014

Background Because abobotulinumtoxinA treatment for glabellar lines must be repeated regularly to prevent recurrence, understanding the safety and effectiveness of long-term, repeated administration of abobotulinumtoxinA is important. Objective To report the long-term safety and efficacy of abobotulinumtoxinA in patients with moderate to severe glabellar lines. Methods and Materials AbobotulinumtoxinA was administered to 1,415 patients in multiple cycles over 24 months as a fixed dose of 50 U or as a dose based on muscle mass and sex (women: 50-70 U; men: 60-80 U). Adverse events were assessed after each visit on days 7, 14, and 30 and monthly thereafter; monitoring continued every 3 months for a total safety monitoring duration of 36 months or less. Results Nine hundred ninety-one (70%) patients reported treatment-emergent adverse effects (TEAEs); most events were mild (70%) or moderate (20%) in severity. The rate of TEAEs did not increase over 24 months of repeated treatment (mean 5.6 cycles; range 1-9). Treatment-related eyelid ptosis followed 53 of 7,938 (0.7%) treatments, all of which resolved spontaneously. Conclusions Multiple cycles of abobotulinumtoxinA treatment over 24 months were well tolerated and effective for the correction of glabellar lines, with no evidence of cumulative safety problems. © 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.


Schlessinger J.,Advanced Skin Research Center | Monheit G.,Dermatology Associates | Kane M.A.C.,Ear and Throat Hospital | Mendelsohn N.,Premier Healthcare Resource
Dermatologic Surgery | Year: 2011

BACKGROUND: A new botulinum neurotoxin type A formulation, abobotulinumtoxinA (BoNTA-ABO; Medicis Aesthetics Inc., Scottsdale, AZ), was approved in 2009 in the United States for treatment of moderate to severe glabellar lines in adults younger than 65. OBJECTIVE To determine onset of response based on participant assessments recorded from days 1 through 7. MATERIALS & METHODS Time to onset was assessed as a secondary endpoint in four multicenter, double-blind, placebo-controlled, randomized phase 3 trials evaluating BoNTA-ABO efficacy. Participants received 50 to 80 U of BoNTA-ABO (n=1,160) or placebo (n=580) at five injection sites in the glabellar region. Participants self-evaluated and recorded first effects. RESULTS Response on day 1 was 13.4% to 32.5% in participants receiving BoNTA-ABO and 3% to 7% in those receiving placebo. Integrated analysis of three studies showed that 19.7% of participants responded by day 1; median onset was 3 days for BoNTA-ABO and 15 days for placebo. Men responded less frequently in fixed-treatment studies than in the study in which doses were adjusted for muscle mass. CONCLUSIONS Treatment with BoNTA-ABO demonstrates significantly greater reduction in glabellar lines than placebo. Improvement was seen as early as 24 hours, with median time to onset of 2 to 4 days. This study was supported by Medicis. The authors received compensation for their research efforts. Naomi Mendelsohn, PhD, a consultant and writer for Premier Healthcare Resource, Inc., Morristown, NJ. [Correction added after online publication 11-Jul-2011: Supported by Allergan udpated to Medicis. Naomi Mendelshohn's affiliation updated.] © 2011 by the American Society for Dermatologic Surgery, Inc.


Schlessinger J.,Advanced Skin Research Center | Schlessinger D.,Advanced Skin Research Center | Schlessinger B.,Advanced Skin Research Center
Journal of Clinical and Aesthetic Dermatology | Year: 2010

Objectives: The authors sought to examine and assess cosmetic surgery patient demographics as well as age in relation to partner, in a prospective manner, analyzing data for any significant correlations. Design: The authors conducted a prospective study utilizing a survey. Setting: The study was conducted in a private, nonacademic dermatological practice. Participants: Three hundred thirty-six patients participated in this study. Results: Demographics of onabotulinumtoxinA/abobotulinumtoxinA (neurotoxins), fillers, and laser hair removal users were studied. The data show that the average private practice cosmetic surgery patient in this study is a married (67.5%), college-educated or greater (66.9%), employed (74.3%), mother (74.5%). In the fillers category, 50 percent of women were older than their partners, as opposed to 14.8 percent in 2008 Census data. Additionally, women were more educated and employed to a higher percentage than similar women in 2008 Census data. Data on motivations were statistically not significant. Conclusion: Data from this study show potential correlations with Census data norms in marital status and motherhood status categories, but not in the age in relation to partner, education, and employment level categories. Motivations of individuals undergoing cosmetic surgery will need further analysis in future studies. © 2010 The Journal of Clinical and Aesthetic Dermatology.


PubMed | Advanced Skin Research Center
Type: Clinical Trial, Phase III | Journal: Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] | Year: 2014

Because abobotulinumtoxinA treatment for glabellar lines must be repeated regularly to prevent recurrence, understanding the safety and effectiveness of long-term, repeated administration of abobotulinumtoxinA is important.To report the long-term safety and efficacy of abobotulinumtoxinA in patients with moderate to severe glabellar lines.AbobotulinumtoxinA was administered to 1,415 patients in multiple cycles over 24months as a fixed dose of 50U or as a dose based on muscle mass and sex (women: 50-70U; men: 60-80U). Adverse events were assessed after each visit on days 7, 14, and 30 and monthly thereafter; monitoring continued every 3months for a total safety monitoring duration of 36months or less.Nine hundred ninety-one (70%) patients reported treatment-emergent adverse effects (TEAEs); most events were mild (70%) or moderate (20%) in severity. The rate of TEAEs did not increase over 24months of repeated treatment (mean 5.6cycles; range 1-9). Treatment-related eyelid ptosis followed 53 of 7,938 (0.7%) treatments, all of which resolved spontaneously.Multiple cycles of abobotulinumtoxinA treatment over 24months were well tolerated and effective for the correction of glabellar lines, with no evidence of cumulative safety problems.

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